FDA.reportPublic FDA data

Intellisense™ Pediatric Defibrillation Pads Powerheart® G5

Primary DI
00812394020171
Brand
Intellisense™ Pediatric Defibrillation Pads Powerheart® G5
Company
Cardiac Science Corporation
Model
XELAED003A
Catalog number
XELAED003A
Device description
Intellisense Pediatric Defibrillation Pads, reduced energy, for Powerheart G5 (up to 8 years of age or 55 lbs)
Published
2015-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MKJAutomated External Defibrillators (Non-Wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122758000POWERHEART G5 AEDCardiac Science Corporation2014-02-12MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812394020171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812394020171008123940201718123940201710812394020171

GMDN Terms#

Term, Definition table
TermDefinition
External defibrillator electrode, paediatric, single-useAn electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator to a pre-pubescent patient in order to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. It typically consists of a cable set [with a connector for insertion into the external pulse generator (EPG)] that terminates with small-diameter, self-affixing pads (the electrodes) prefabricated with contact gel and an adhesive, that are applied to the chest (the intact torso) of the patient so that the discharge passes across the region of the heart. This device may remain applied to the patient during stages of treatment. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1.262.953.3500techsupport@cardiacscience.com

Regulatory Flags#

DUNS number
190713797
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812394020102Powerheart® Adult Defibrillation Pads9131-0012014-09-29
00812394020126Intellisense Adult Defibrillation Pads, Powerheart® G5XELAED001AXELAED001A2015-04-29
00812394020249Powerheart® Polarized Adult Defibrillation Pads9660-0019660-0012014-09-29
00812394020492Intellisense Adult Defibrillation Pads, Powerheart® G5XELAED001BXELAED001B2015-12-18
00812394020522Intellisense Adult Defibrillation Pads, CPR Device, Powerheart® G5XELAED002AXELAED002A2015-12-21
00812394020584Powerheart® Polarized Adult Defibrillation Pads2019199-0082019199-0082015-07-24
00812394020591Powerheart® Adult Defibrillation Pads2019199-0022019199-0022015-07-24
00812394020416Powerheart AED G3 Pro ECG Monitoring Cable5111-0015111-0012017-02-09
00812394020256Powerheart®Pediatric Pads9730-0029730-0022014-09-29
00812394020515Intellisense™ Pediatric Defibrillation Pads Powerheart® G5XELAED003BXELAED003B2015-12-18
00812394020607Powerheart®Pediatric Pads2019199-0032019199-0032015-07-24
00812394020041Powerheart® G5 Semi Automatic AEDG5S-01P0G5S-01P02015-01-01
00812394020133Intellisense® Battery Powerheart® G5XBTAED001AXBTAED001A2015-04-29
00812394020140Powerheart® G5 Semi Automatic AEDG5S-01AG5S-01A2015-01-01
00812394020157Powerheart® G5 Automatic AEDG5A-01AG5A-01A2015-01-01
00812394020164Powerheart® G5 Automatic AED G5A-01P0G5A-01P02015-01-01
00812394020232Powerheart® AED G3 Plus Automatic AED9390A-10019390A-10012014-09-29
00812394020331Powerheart® AED G3 Plus Automatic AED9390A-019390A-012014-09-29
00812394020362Powerheart® AED G3 Plus Automatic AED9390A-1001-SUNY9390A-1001-SUNY2014-09-29
00812394020379Powerheart® AED G3 Plus Automatic AED9390A-1001-TSO9390A-1001-TSO2014-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812394027279RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
10812394027276RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
00197644380145AED Battery ExchangeAED BATTERY EXCHANGE, LLCMKJ2026-04-15
00810149098291R&D Batteries, Inc.R & D Batteries, Inc.MKJ2026-04-01
10847946001435PEDI PADZZoll Medical CorporationMKJ2026-02-12
10847946016231ONESTEPZoll Medical CorporationMKJ2026-02-12
10847946023345ONESTEPZoll Medical CorporationMKJ2026-02-12
00810149098208R&D Batteries, Inc.R & D Batteries, Inc.MKJ2025-11-19
20192253017516KendallCardinal Health 200, LLCMKJ2024-02-28
20192253017530KendallCardinal Health 200, LLCMKJ2024-02-28
20192253017561Medi-Trace CadenceCardinal Health 200, LLCMKJ2024-02-28
20192253017608Medi-Trace CadenceCardinal Health 200, LLCMKJ2024-02-28
10009336010322Zoll PL DefibGRAPHIC CONTROLS ACQUISITION CORPMKJ2023-10-30
10653405046813CONMEDConmed CorporationMKJ2023-10-19
20192253017714KendallCardinal Health 200, LLCMKJ2023-06-15
10884838002859HeartStartPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-02-25
10884838002842HeartStart Adult/Child Plus PadsPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-01-06
10884838002866HeartStartPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-01-06
10884838022048Adult/Child Pre-Connect Defib PadPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-01-06
20192253017554Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-08-19
20192253017622Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-08-19
20192253018865Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-08-19
20192253017578Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253017585Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253017639Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253018872Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253018889Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253017547Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-28
20192253017295KendallCardinal Health 200, LLCMKJ2021-05-06
20192253017455KendallCardinal Health 200, LLCMKJ2021-05-05